When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

Earlier this year, the Food and Drug Administration approved a new drug for treating cystic fibrosis for patients who have a specific genetic mutation, but that also treats the underlying cause of the disease rather than the disease itself.

The Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, on Monday sought a permanent injunction against the dietary supplement manufacturer James G. Cole; its president, James Cole; and its general manager, Julie Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug and Cosmetic Act.

Researchers have begun the first definitive, large-scale clinical trial to investigate if a vitamin D supplement helps prevent or delay Type 2 diabetes in adults who have prediabetes and are at high risk for developing Type 2.

Poll

Poll

Which of the current U.S. Presidential hopefuls do you think would be best for your business?

Hillary Clinton

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SPECIAL REPORTS

Pharmacy’s battle for recognition continues

Fifty years ago this summer, President Lyndon B. Johnson secured his place in history by signing into law the legislation that created Medicare and Medicaid. To commemorate the anniversary, Drug Store News has put together an exclusive report on the effect that Medicare and Medicaid have had on the retail pharmacy industry and how it has transformed the role of the pharmacist. more...

IN THIS ISSUE

In this issue, DSN profiles Rite Aid and how the company is achieving a vision to become a retail healthcare company that delivers a higher level of care to its communities; takes you on a tour of Sears; offers insight into millennial shoppers and more. Click here to view the issue.